Industry Roundup: FTC, FDA Enforcement, Soft Chew, Bulu Mining

FTC clear on gray area of supplement claims; Soft Chew adds to GNC offerings; Aldrin in Re Muscle Health’s orbit; and more news in brief.

FTC clear on gray area of supplement claims

Two firms that claimed their dietary supplements could prevent or reverse gray hair settle Federal Trade Commission charges of unfounded claims while a third firm, referred to the agency in industry self-regulation, is targeted for making similar claims. FTC on May 15 said it filed a complaint in federal court in Wyoming against Coorga Nutraceuticals Corp. and its principal Garfield Coore, marketer of the Grey Defence line with claims including “65% of Grey Defence customers in [an] observational study reversed their grey! Grey Defence reverses greying – detailed observational study proves it.” The National Advertising Division in January 2014 referred the Grey Defence ad claims to FTC after the Cheyenne, Wyo., firm declined to submit evidence in support of its claims (Also see "In Brief: Bayer bonds, Nestle investment, P&G and Abbott earnings, NAD reviews" - Pink Sheet, 27 Jan, 2014.).

FTC also announced proposed orders to prohibit Charleston, S.C., firm GetAwayGrey LLC and Rise-n-Shine LLC, of Sparta, N.J., from representing that a supplement product reverses or prevents the formation of gray hair, and from making any claim about the health benefits, performance or efficacy of any supplement unless the claim is non-misleading and the firms have competent and reliable scientific evidence as substantiation. The orders require the firms to retain certain records of human clinical testing they rely on as competent and reliable scientific evidence. A judgment of $1.8 million was suspended against GetAwayGrey and a $2 million judgment against Rise-n-Shine was suspended, though the firms could be required to pay if they are found to have misrepresented their financial condition.

More Soft Chew supplements in GNC

Nutritional confectionery products marketer Healthy Delights introduces five products in GNC stores nationwide to position the firm to grow its brand and further its stance as the “go-to soft chew supplement to stay healthy,” the West Palm Beach, Fla., company said May 18. The products Probiotic Chocolate Bites, Probiotic Greek Yogurt Bites, Turmeric Curcumin Chews, Magnesium Chews and Cranberry Chews joined other Healthy Delights products on shelves in [GNC Holdings Inc.] stores. A fully branded in-store display will offer customers a free sample of the supplements, priced between $19.99 and $25.99 for 30-count packages. “Healthy Delights was developed with the goal of delivering high-quality supplements and nutritional snacks in a delicious and convenient way,” said Healthy Delights marketing executive Al Baumeler.

Aldrin in Re Muscle Health’s orbit

Former astronaut Buzz Aldrin, a paid board member of Re Muscle Health, puts his advocacy where his money is, promoting the firm’s products – in addition to regular exercise – to maintain lean muscle at the age of 85. “I am pleased that Re Muscle Health is tailored to the aging population as well as athletes and the fitness community,” said Aldrin in a May 19 release by Re Muscle’s parent firm, Cedar Knolls, N.J., marketer MYOS Corp. “Given the extraordinary rigors of space travel on the human body, as well as the physical challenges of living in a zero gravity environment, unraveling the biology around muscle loss occurring during weightlessness and as a consequence of illness and immobility is one of the great opportunities I see for MYOS to develop therapeutic solutions in the future,” said Aldrin. The Re Muscle Health series, in six flavors, is available online. Earlier in 2015 MYOS said it would promote the range through product trials and events (Also see "Consumer Health New Products Roundup" - Pink Sheet, 6 Apr, 2015.).

Drug claims by Louisiana supplement firm

Pick and Pay Inc., which markets dietary supplements as Cili Minerals, makes claims for its products including “might help mental disorders” and germanium “is used for heart and blood vessel conditions, including high blood pressure, high cholesterol and heart disease,” according to FDA. The Office of Regulatory Affairs New Orleans District stated in a May 8 warning letter that product labels and the website made claims that establish the products branded PoLith, CilZinCo, Cilver,ADD-Ease and others as drugs. The products also are misbranded because labels for some fail to bear adequate direction for use and others do not state “dietary supplement” or include the place of business of the manufacturer, packer or distributor on the label, FDA notes. Supplement good manufacturing practice regulation violations also were found at the Lafayette, La.-based firm.

Natural Alternatives’ sales grow on patents

Natural Alternatives International Inc.’s net sales for the January-March period rose 2.5% to $19.6 million, with new product sales offset by lower sales of established products, says the nutritional supplement formulator, manufacturer and marketer. However, first-quarter net income grew 26.7% to reach $788 million as patent and trademark licensing revenue jumped 100.7% to $2.3 million, noted the San Marcos, Calif., firm. NAI achieved Natural Food Certifiers’ clearance as an organic processor and handler under the USDA National Organic Program Standards.

Nutritional sampler Bulu scores data mining funding

Sample box marketer Bulu Box, which features vitamins, supplements and health snacks in its packages, secures $1.5 million in funding to launch Bulu Insights proprietary software that aggregates a “vast trove of data acquired from over 1 million sample surveys into an easy-to-use real-time dashboard.” The funding was provided by venture capital firm Flyover Capital. Bulu Insights is designed to utilize data Bulu Box collects including consumer sample surveys, user profiles and purchase behavior, to provide its partnering firms – which have included Shapeology Nutrition, QuestNutrition and Neocell – product and consumer intelligence insight while getting their samples to qualified, paying customers, the Lincoln, Neb., firm said May 8.

Cactus juice refunds mailed

The Federal Trade Commission mails around $3 million among nearly 500,000 checks to consumers who bought Trivita Inc.’s unsupported claims that its cactus-based drink Nopalea would treat a variety of health problems. In July 2014, FTC settled charges against Trivita, including that the Scottsdale, Ariz., firm used infomercials with testimonials from consumers who received a commission for selling its products (Also see "Wellness Drink Firm Trips Over FTC Endorsement Disclosure Bar" - Pink Sheet, 21 Jul, 2014.).

Cannabis firm appoints security head

Valley Agriceuticals LLC, dedicated to “raising the industry standard for pharmaceutical-grade medical cannabis production” and bringing medical cannabis to patients throughout New York, appoints John Cutter as chief security officer. Cutter will develop an “unparalleled program of security protocols that will adhere to local, state and federal security regulations, including crime prevention,” which will cover the complete life cycle of the company's products including cultivation, production, packaging, tracking, transportation and distribution at the firm's dispensaries, the Purchase, N.Y., firm said May 14. Cutter has more than 30 years of experience in security, intelligence and law enforcement.

Earth Science finds leaders

Earth Science Tech Inc. appoints Matthew Cohen CEO and chief financial officer and Thomas H. Wright III chief operating officer. Both men also were named board members for the Boca Raton, Fla., biotechnology company focused on nutraceuticals, bioceuticals and dietary supplements. Cohen's experience includes establishing and implementing organizational systems controls, policies, and procedures for public and private corporations.

Wright is a partner at the law firm Siegel Siegel & Wright in Boca Raton focused on areas of law including corporate matters, intellectual property, drug crimes, synthetic drug testing, medical marijuana and high-cannabidoil products.